ERIVEDGE Drug Patent Profile
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When do Erivedge patents expire, and when can generic versions of Erivedge launch?
Erivedge is a drug marketed by Genentech and is included in one NDA. There are three patents protecting this drug.
This drug has fifty-three patent family members in twenty-four countries.
The generic ingredient in ERIVEDGE is vismodegib. One supplier is listed for this compound. Additional details are available on the vismodegib profile page.
DrugPatentWatch® Generic Entry Outlook for Erivedge
Erivedge was eligible for patent challenges on January 30, 2016.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be November 11, 2028. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for ERIVEDGE
International Patents: | 53 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 126 |
Clinical Trials: | 46 |
Patent Applications: | 1,768 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ERIVEDGE |
What excipients (inactive ingredients) are in ERIVEDGE? | ERIVEDGE excipients list |
DailyMed Link: | ERIVEDGE at DailyMed |


DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ERIVEDGE
Generic Entry Date for ERIVEDGE*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for ERIVEDGE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
H. Lee Moffitt Cancer Center and Research Institute | Early Phase 1 |
Genentech, Inc. | Early Phase 1 |
Ronald Buckanovich | Phase 2 |
Pharmacology for ERIVEDGE
Drug Class | Hedgehog Pathway Inhibitor |
Mechanism of Action | Smoothened Receptor Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for ERIVEDGE
US Patents and Regulatory Information for ERIVEDGE
ERIVEDGE is protected by three US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ERIVEDGE is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting ERIVEDGE
Pyridyl inhibitors of hedgehog signalling
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pyridyl inhibitors of hedgehog signalling
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF USING VISMODEGIB TO TREAT CANCER IN A MAMMAL
Pyridyl inhibitors of hedgehog signalling
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF USING VISMODEGIB TO TREAT BASAL CELL CARCINOMA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Genentech | ERIVEDGE | vismodegib | CAPSULE;ORAL | 203388-001 | Jan 30, 2012 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Genentech | ERIVEDGE | vismodegib | CAPSULE;ORAL | 203388-001 | Jan 30, 2012 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Genentech | ERIVEDGE | vismodegib | CAPSULE;ORAL | 203388-001 | Jan 30, 2012 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for ERIVEDGE
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Roche Registration GmbH | Erivedge | vismodegib | EMEA/H/C/002602 Erivedge is indicated for the treatment of adult patients with:- symptomatic metastatic basal cell carcinoma- locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy |
Authorised | no | no | no | 2013-07-12 | 2013-04-26 |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ERIVEDGE
When does loss-of-exclusivity occur for ERIVEDGE?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 05282722
Estimated Expiration: ⤷ Try a Trial
Patent: 11201229
Estimated Expiration: ⤷ Try a Trial
Patent: 13219216
Estimated Expiration: ⤷ Try a Trial
Patent: 16203958
Estimated Expiration: ⤷ Try a Trial
Patent: 17261491
Estimated Expiration: ⤷ Try a Trial
Patent: 19226273
Estimated Expiration: ⤷ Try a Trial
Patent: 21205133
Estimated Expiration: ⤷ Try a Trial
Austria
Patent: 2768
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0514841
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 79002
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1072755
Estimated Expiration: ⤷ Try a Trial
Patent: 2964294
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 12630
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 89390
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 7262
Estimated Expiration: ⤷ Try a Trial
Patent: 0700538
Estimated Expiration: ⤷ Try a Trial
Patent: 1100604
Estimated Expiration: ⤷ Try a Trial
Patent: 1890903
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 89390
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 300068
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 1673
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 43558
Estimated Expiration: ⤷ Try a Trial
Patent: 08511675
Estimated Expiration: ⤷ Try a Trial
Patent: 12184255
Estimated Expiration: ⤷ Try a Trial
Patent: 14148537
Estimated Expiration: ⤷ Try a Trial
Luxembourg
Patent: 278
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 07002584
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 9385
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 9260
Estimated Expiration: ⤷ Try a Trial
Patent: 071719
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 89390
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 89390
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 89390
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 0702537
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1225018
Estimated Expiration: ⤷ Try a Trial
Patent: 1366414
Estimated Expiration: ⤷ Try a Trial
Patent: 070085243
Estimated Expiration: ⤷ Try a Trial
Patent: 120139846
Estimated Expiration: ⤷ Try a Trial
Patent: 130083488
Estimated Expiration: ⤷ Try a Trial
Patent: 140048343
Estimated Expiration: ⤷ Try a Trial
Patent: 150002863
Estimated Expiration: ⤷ Try a Trial
Patent: 150090263
Estimated Expiration: ⤷ Try a Trial
Patent: 160058972
Estimated Expiration: ⤷ Try a Trial
Patent: 170001725
Estimated Expiration: ⤷ Try a Trial
Patent: 180122750
Estimated Expiration: ⤷ Try a Trial
Patent: 190072678
Estimated Expiration: ⤷ Try a Trial
Patent: 200019263
Estimated Expiration: ⤷ Try a Trial
Patent: 200118909
Estimated Expiration: ⤷ Try a Trial
Patent: 210090744
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 77430
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 565
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering ERIVEDGE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 20160058972 | 헤지호그 신호전달에 대한 피리딜 억제제 (PYRIDYL INHIBITORS OF HEDGEHOG SIGNALLING) | ⤷ Try a Trial |
Canada | 2579002 | INHIBITEURS PYRIDYLES DE LA SIGNALISATION HEDGEHOG (PYRIDYL INHIBITORS OF HEDGEHOG SIGNALLING) | ⤷ Try a Trial |
European Patent Office | 1789390 | INHIBITEURS PYRIDYLES DE LA SIGNALISATION HEDGEHOG (PYRIDYL INHIBITORS OF HEDGEHOG SIGNALLING) | ⤷ Try a Trial |
Eurasian Patent Organization | 017262 | СОЕДИНЕНИЯ 2-(2-ГАЛОГЕН-4-АМИНОФЕНИЛ)ПИРИДИНОВЫХ ИНГИБИТОРОВ ПЕРЕДАЧИ СИГНАЛОВ БЕЛКОМ HEDGEHOG (ВАРИАНТЫ), СПОСОБ ИХ ПОЛУЧЕНИЯ, КОМПОЗИЦИЯ И СПОСОБЫ ЛЕЧЕНИЯ РАКА И ИНГИБИРОВАНИЙ АНГИОГЕНЕЗА И СИГНАЛЬНОГО ПУТИ HEDGEHOG В КЛЕТКАХ НА ИХ ОСНОВЕ (COMPOUNDS OF 2-(2-HALOGEN-4-AMINOPHENYL)PYRIDYL INHIBITORS OF HEDGEHOG SIGNALING (EMBODIMENTS), PROCESS FOR PREPARING SAME, COMPOSITION AND METHODS FOR TREATING CANCER AND INHIBITING ANGIOGENESIS AND HEDGEHOG PATHWAY SIGNALING IN CELLS BASED THEREON) | ⤷ Try a Trial |
Poland | 1789390 | ⤷ Try a Trial | |
Japan | 2012184255 | HEDGEHOG SIGNAL TRANSDUCTION PYRIDYL INHIBITOR | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ERIVEDGE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1789390 | 2014/002 | Ireland | ⤷ Try a Trial | PRODUCT NAME: ERIVEDGE-VISMODEGIB OR A SALT OR SOLVATE THEREOF; NAT REGISTRATION NO/DATE: EU/1/13/848 20130712; FIRST REGISTRATION NO/DATE: 62497 01 20130530 |
1789390 | C 2013 038 | Romania | ⤷ Try a Trial | PRODUCT NAME: VISMODEGIB SI SARURILE SI SOLVATIIACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/848; DATE OF NATIONAL AUTHORISATION: 20130712; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): CH 62497 01; DATE OF FIRST AUTHORISATION IN EEA: 20130530 |
1789390 | 170 12-2013 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: VISMODEGIB; REGISTRATION NO/DATE: EU/1/13/848/001 20130712 |
1789390 | 122013000074 | Germany | ⤷ Try a Trial | PRODUCT NAME: ERIVEDGE - VISMODEGIB; NAT. REGISTRATION NO/DATE: EU/1/13/848 20130712; FIRST REGISTRATION: SCHWEIZ IKS-NR. 62497 20130530 |
1789390 | 14C0002 | France | ⤷ Try a Trial | PRODUCT NAME: VISMODEGIB AINSI QUE SES SELS ET SOLVATES; NAT. REGISTRATION NO/DATE: EU/1/13/848 20130712; FIRST REGISTRATION: IKS 62497 20130530 |
1789390 | 1390057-6 | Sweden | ⤷ Try a Trial | PERIOD OF VALIDITY (FROM - UNTIL): 2025-09-03 - 2028-07-16 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |